You are better off traveling overseas for actual therapy than considering a clinical trial in the USA.
Clinical trials for humans relating to autologous adult stem cell therapy should be abolished, strongly curtailed, or modified. Clinical trials have no place in stem cell studies because each patient can serve as his or her own control. The supposed yet outdated requirement for clinical studies involving a patient control group is being used by the medical establishment to bar stem cell therapies in the US, and is one of many reasons why the US lags behind other countries in advancing stem cell therapies.
Stem Cell therapy with autologous adult stem cells constitutes the “New Medicine”. With all the modern technology for objective scientific assessment of a patient’s medical condition, there is no need for a randomized study. Each patient can be carefully evaluated, before and after treatment, by objective medical testing using various equipment, and their condition after therapy compared to that before. Consequently, the treatment of each individual patient constitutes a “single patient clinical trial”. Moreover, the outdated clinical trial format is not relevant nor applicable to “patient specific” therapy involving adult stem cells or even adult fetal stem cells.
Moreover, the fact of the matter is that the so called “clinical trials”, the gauntlet that new medical applications and drugs must run in order to become approved, are immoral. A clinical trial is a study in which 1/2 of the patients are given no treatment. They are the “control group”. Would you ever want to be in the “control group”, needing treatment and getting none??
One questions what kind of informed consent is obtained from patients who will receive no treatment. Are they invited “to be part of a study” and therefore believe they will all be receiving some new experimental treatment?? This appears to some to be a medical fraud.
Professor Georges Mathé, a well respected pioneer in stem cell transplantation and winner of the Grand Medal of the National Academy of Medicine (France’s highest medical honor) gave a lecture in 1998 entitled: “From Moral via Ethics to the Politically Correct”. He discussed how ethics boards determine what is ethical, and thereby change the publics’ perception of what is moral. He stated: ”One of the most immoral such acts concerns medical experimentation. Most people are unaware that 500 patients are chosen at random to receive a “placebo”, while 500 others are given an experimental drug.” [Excerpted from the lecture given at the World Philosophers Meeting , Geneva, Switzerland 1998].
One might also find it strange that, although scarcely reported, more and more so called “clinical trials” are being performed overseas outside of the USA. A whole new industry has formed over the last 5-10 years to perform clinical trials overseas. If these “studies” are so great for a patient to be involved in, why are they being sent overseas? One would suspect it is because the level of informed consent, if any, is probably a lot more lax overseas. Almost 1/2 of US clinical trials are being conducted overseas, with India’s share growing each year.
A better approach is that used in Thailand, in which ALL patients receive the proposed treatment regimen. There is no “control group” receiving nothing. Each patient serves as his/her own control. Particularly in the case where patients receive products of their own blood and tissues, such as autologous stem stem cells, there is no need for controlled studies. See for example: Chaithiraphan,S et al.: Transcoronary Injection of Angiogenic Cells Precursors and Autologous Stem Cells in Ischemicc Cardiomyopathy: A Clinical Study of 106 Cases in Thailand. Asean Heart Journal, 17(No.1): 13-22, 2009. Outcomes are compared to the patients’ condition prior to the treatment to determine its efficacy.
Conclusion
Clinical trials, which are one of the foundations of modern medicine, should be abandoned or modified for stem cell studies. This type of experimentation is certainly appropriate for animal studies but not for humans. First, stem cell therapy does not involve any drug. Particularly with respect to the injection of autologous stem cells (that are found naturally in the patient), the patient is receiving what one already has, just more of it. Second, with all the modern technology for objective scientific assessment of a patient’s medical condition, there is no need for a randomized study. Each patient can be carefully evaluated, before and after treatment, by objective medical testing using various equipment, and their condition after therapy compared to that before. Why is such a collection of testing evidence using modern scientific equipment not sufficient to ensure that a positive beneficial effect of a stem cell treatment with autologous adult stem cells is well documented, and hence, “proven”???
“Clinical Trial” requirements, for treatments involving autologous adult stem cells, should be modified so as to focus not on who is included in the study and their treatment protocol, but rather to focus on the identity of the appropriate medical tests to define the patient’s condition before and after treatment.
If just this one small change were to be made, stem cell treatment with autologous adult stem cells could proceed in the US at am amazing pace!!
The US as well as other countries should modify their guidelines relating to patient treatments with autologous stem cells to be more in line with other countries such as Thailand that are using stem cell treatments now in a variety of diseases and conditions. This is a much more modern and humane approach. The concept of always requiring a “randomized control study” is simply not applicable to stem cell therapies with autologous stem cells because the treatment of each individual patient constitutes a “single patient clinical trial”. Moreover, the outdated clinical trial format is not relevant nor applicable to “patient specific” therapy involving adult stem cells or even adult fetal stem cells.
